Useful Advices - Business

The Sarbanes-Oxley Act of 2002, adopted as a reaction to corporate scandals, has a significant impact on European companies. The reason is simple: Hundreds of European-headquartered companies are dually listed on two stock

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

exchanges, one in Europe and the other in the United States. 470 non-US companies are listed on the New York Stock Exchange, with a combined market capitalization of $3.8 trillion, 30 per cent of the total value of capita

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ization of companies quoted on the exchange.

EU Data Protection DirectiveWhat is personal data (according to EU)? Personal data can be any information relating to an identified or identifiable natural person (directly or

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ndirectly): Name, telephone number, photos. Data specific to his physical, physiological, mental, economic, cultural or social identity. What is processing of personal data? Any operation performed upon personal data wheth

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

r or not by automatic means.

Data Controllers must adhere to the following rules: Data must be relevant and not excessive in relation to the purpose for which they are processed. Data must be accurate. Data controllers ar

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

required to provide reasonable measures for data subjects to rectify erase or block incorrect data about them. The directive prohibits transfer of personal information to countries outside the EU, which lack adequate prot

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ction of privacy.

Sarbanes OxleySection 301. Public company audit committees: Each audit committee shall establish procedures for: (A) The receipt, retention, and treatment of complaints received by the issuer regarding a

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

counting, internal accounting controls, or auditing matters; and (B) The confidential, anonymous submission by employees of the issuer of concerns regarding questionable accounting or auditing matters.

The challenge How

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

US company with offices throughout the EU can comply with the notice and choice principles of EU Data Protection laws while simultaneously complying with the whistle blower requirements under Sarbanes Oxley?

How can we h

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ve both: 1. A Sarbanes Oxley hotline reporting service for employees to use anonymously, and 2. A Data Protection control: Data subjects must learn, rectify, erase or block incorrect data about them.

The problems On 14 J

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ne 2005 the French Data Protection Authority refused to authorize the use of anonymous whistleblower hotlines. The French Authority's view was that such hotlines are "disproportionate to the objectives sought and the risks

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

of slanderous denunciations and the stigmatization of employees who were the subjects of an ethics alert."

In a similar decision a German labor court ruled that parts of an employee code of conduct inviting employees to

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

eport misconduct to a whistleblowers hotline breached German labor law. Early indications from the UK Information Commissioners Office (ICO) are that they would decline to follow the French and German approach. In contras

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

to the French and German decisions, the ICO's view is that the appropriate use of such helpline by organizations would not, in principle, raise data protection concerns. However, where organizations misuse such anonymous

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

otlines for inappropriate information gathering purposes there may be data protection implications.

Recommendations Companies that are publicly traded in the United States and also have operations in the European Union m

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

st be very careful with the whistleblower provisions of the U.S. Sarbanes-Oxley Act of 2002.

First of all, before implementing Sarbanes Oxley hotline reporting services, companies need to ask for permission from the local

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Data Protection Authority.

Complaints must be processed inside the European Union. Companies need to establish local investigation procedures. The suspected person would be given the opportunity to comment within two days

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

In the event that the investigation shows that the allegations were unfounded, the data must be deleted within two days of the case closure. If the allegations are determined to be well-founded, then the file would be kep

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

for one to five years after the case was closed (depending on management level).

Can EU really protect employees from the whistleblower provisions?No. If a U.S. public company lists on its website or intranet site that i

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

has a telephone number or email address where anonymous complaints can be received, even if that site is not addressed to or publicized in EU, an employee in Europe may still go to the site and file an anonymous complaint

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Useful Advices - Sarbanes Oxley Europe: The EU Data Protection Directive vs. Sarbanes Oxley Whistleblower Protection

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